SPECIAL ARTICLE

EudraVigilance Medicines Safety Database: Publicly AccessibleData for Research and Public Health Protection

Rodrigo Postigo1• Sabine Brosch1

• Jim Slattery1• Anja van Haren2

•

Jean-Michel Dogne3• Xavier Kurz1

• Gianmario Candore1• Francois Domergue1

•

Peter Arlett1

Published online: 9 March 2018

� The Author(s) 2018. This article is an open access publication

Abstract The analysis of safety data from spontaneous

reporting systems has a proven value for the detection and

analysis of the risks of medicines following their placement

on the market and use in medical practice. EudraVigilance

is the pharmacovigilance database to manage the collection

and analysis of suspected adverse reactions to medicines

authorised in the European Economic Area. EudraVigi-

lance first operated in December 2001, with access to the

database being governed by the EudraVigilance access

policy. We performed a literature search including data up

to December 2016 to demonstrate how the data from

EudraVigilance has been used in scientific publications.

We describe the results, including by type of publication,

research topics and drugs involved. In 50% of the publi-

cations, the data are used to describe safety issues, in 44%

to analyse methodologies used in pharmacovigilance

activities and in 6% to support clinical perspectives. We

also outline a description of the use of the database by the

European Union regulatory network. Driven by the full

implementation of the 2010 pharmacovigilance legislation,

EudraVigilance has undergone further enhancements

together with a major revision of its access policy, taking

into account the use of the new individual case safety

report standard developed by the International Council for

Harmonization of Technical Requirements for Pharma-

ceuticals for Human Use and the International Organiza-

tion for Standardization. The aim of the broadened access

is to facilitate more effective safety monitoring of autho-

rised medicines, to make more data available for research

and to provide better access to information on suspected

adverse reactions for healthcare professionals and patients.

In November 2017, the new full functionalities of

EudraVigilance were launched, including the extensive

web access to data on suspected adverse drug reactions and

the possibilities for academic research institutions to

request a more extensive dataset for the purposes of health

research. The main objective of this article is to describe

the new access to the database together with the opportu-

nities that this new access can bring for research. It is

intended to promote an appropriate use of the data to

support the safe and effective use of medicines.

Electronic supplementary material The online version of thisarticle (https://doi.org/10.1007/s40264-018-0647-1) contains supple-mentary material, which is available to authorized users.

& Rodrigo Postigo

rodrigo.postigo@ema.europa.eu

1 European Medicines Agency, 30 Churchill Place, Canary

Wharf, London E14 5EU, UK

2 Medicines Evaluation Board, Utrecht, The Netherlands

3 Agence Federale des Medicaments et des Produits de Sante

(Member of the Pharmacovigilance Risk Assessment

Committee), Brussels, Belgium

Drug Saf (2018) 41:665–675

https://doi.org/10.1007/s40264-018-0647-1

Key Points

New EudraVigilance functionalities and the

increased level of access facilitate more effective

monitoring of the safety of medicines. Six different

stakeholder groups with different levels of access

have been defined

Since November 2017, academic research

institutions have the possibility to request extended

access to EudraVigilance data, opening more

possibilities for scientific and medical research

Scientific publications using EudraVigilance data

have increased since 2010 and analyse a wide range

of safety issues, medicinal products, therapeutics

areas, and pharmacovigilance topics and methods

1 Introduction

EudraVigilance (EV) is the system for collecting, manag-

ing and analysing suspected adverse drug reactions (ADRs)

to medicines authorised in the European Economic Area

(EEA). The European Medicines Agency (EMA) operates

the system, which became operational in December 2001,

on behalf of the European Union (EU) medicines regula-

tory network [1].

On 4 February, 2016, 15 years after the pharmacovigi-

lance database was launched, submissions to EV reached

10 million individual case safety reports (ICSRs), making it

one of the biggest spontaneous reporting systems in the

world. This milestone coincided in time with significant

technical enhancements and with a major revision of the

EV access policy aimed at increasing the utility and

accessibility of the ICSR data in line with the pharma-

covigilance legislative requirements [2–4], and thereby at

further contributing to public health protection.

Since November 2005, the electronic reporting of sus-

pected ADRs is mandatory in the EEA [2, 3]. The sub-

mission of ADRs from both marketed use and from trials is

based on the standards agreed at the level of the Interna-

tional Council for Harmonization of Technical Require-

ments for Pharmaceuticals for Human Use [5] and the

International Organization for Standardization [6], which

allow for a structured and standardised way safety infor-

mation is to be collected and exchanged.

By the end of 2017, EV held a total of 12,451,826

ICSRs, referring to 7,948,873 individual cases (one case

can relate to more than one ICSR owing to follow-up

information supplementing and updating initial reports). In

total, 402,690 cases were submitted from interventional

clinical trials and 7,546,183 from the post-authorisation

setting of the medicinal products. Of the cases submitted

from post-authorisation, 64% (4,838,460) were submitted

from outside the EEA and 36% (2,707,723) from EEA

countries. During the course of 2017 alone, 1,076,811

individual cases were transmitted from post-authorisation,

418,383 from EEA countries. Of those, 84,372 were

directly submitted by European patients and consumers

through national competent authorities (NCAs) in the

Member States and marketing authorisation holders

(MAHs). The EEA country distribution of patients’ reports

analysed by Banovac et al. in 2017 [7] showed that the

highest number of reports originated from the Netherlands,

followed by the UK, Germany, France and Italy. The same

five countries contributed 77% of all healthcare profes-

sional reports to EV.

In May 2017, following a period of technical develop-

ment, guideline updates, engagement with the stakeholders

and an independent system audit, the EMA Management

Board announced that the EV database has achieved full

functionality [8]. This triggered the application of both the

simplified reporting rules for NCAs and MAHs and the

extended access to the database with the goal to further

support the safety surveillance of medicinal products in the

EU, increase transparency and enable greater use of the

data by stakeholders, including researchers.

2 Use of EudraVigilance Data

In this section, we review the use of EV data up to

December 2016, including published reviews, with the aim

to provide an overview of their use for health research. The

launch of the enhanced system functionalities and the new

access to data provide the research and medicine safety

communities with the opportunity to make a much greater

use of this data source, and this review therefore serves

both as an inspiration and a challenge.

Use of EV data by the EU regulatory network includes a

summary of areas such as signal detection and evaluation,

PSUR assessments [9] and referrals. During 2017, the

number of signals prioritised and analysed by the Phar-

macovigilance Risk Assessment Committee was 82 and

overall, the source of 63% included data from EV.

In addition to the use of EV by the EU regulatory net-

work, other groups such as healthcare professionals and

patients can obtain information on ADR data submitted to

EV via the ‘European Database of Suspected Adverse Drug

Reactions Reports’ [10] (hereinafter referred to as the

‘ADR website’). This information is available from the

EMA website with guidance on the interpretation of the

666 R. Postigo et al.

data. In 2017, the ADR website registered an average of

17,068 visits per month.

To have an overview about how EV data has been used

in research and scientific publications, a search in

EMBASE [11], PubMed and PubMed Central [12] was

conducted using specific keywords [see the Electronic

Supplementary Material (ESM)]. This provides an illus-

tration of the use of the data with the aim of informing

researchers about how EV can be used. The search inclu-

ded publications up to 31 December, 2016 and retrieved

105 citations referring to publications that contain data

from EV.

Ninety percent of the publications derived from coun-

tries within the EEA and 10% from the rest of the world.

Figure 1 shows a distribution of the publications per

country of the main author (a) and type of publication (b).

Sixty-one percent of the citations from the UK were pub-

lished by EMA personnel.

The publications were classified in: (1) ‘safety issues’

when they describe a safety signal, characterisation of a

risk or characterisation of the general safety profile of the

drug; (2) ‘pharmacovigilance topics’ when the data were

used to analyse a pharmacovigilance activity, research

methodologies (e.g. signal detections methodologies,

pharmacovigilance in paediatric population) or ADR

reporting patterns (e.g. consumer reports, medication

errors); and (3) ‘clinical perspectives’ when the EV data

were used to support clinical practice and treatment guid-

ance discussions.

Figure 2 shows the citations distributed by year of

publication (a) and the main classification of the publica-

tions (b). Within the time distribution, there is a marked

increase after 2012–2013 probably driven by the imple-

mentation of the 2010 pharmacovigilance legislation and

the increased accessibility of the data, including through

the release of the public ADR website [10].

Together with the EV data, the publications are sup-

ported by other sources of information. These include

spontaneous reporting systems such as the World Health

Organization (WHO) global database of individual case

safety reports (VigiBase) [13], the US Vaccine Adverse

Event Reporting System [14], the US FDA Adverse Event

Reporting System [15], NCAs databases and safety data-

bases from MAHs. Furthermore, data is provided from

electronic health records databases, health insurance com-

panies, legal datasets and patient registries. In 63% of the

Fig. 1 Publications using EudraVigilance data up to 31 December, 2016, classified per country of author and type of publication (as per the

classification stated in EMBASE). Absolute numbers. EMA European Medicines Agency

EudraVigilance Medicines Safety Database: Publicly Accessible Data 667

Fig. 2 Publications per year and the main classification of the publications using EudraVigilance data up to 31 December, 2016. Absolute

numbers

Fig. 3 Anatomical Therapeutic Chemical (ATC) code classification of the drugs analysed in the publications using EudraVigilance data to

describe safety issues up to 31 December, 2016. Absolute numbers. excl excluding

668 R. Postigo et al.

publications retrieved, EV is the sole spontaneous reporting

system used for the research.

The specific drug-related safety issues are summarised

in the ESM for this article including the drugs involved and

the databases used for the analysis. The classification of

drugs for which data are analysed in the 53 (50%) publi-

cations related to safety issues shows interests in a wide

range of therapeutic areas, from medications administered

presumably to relatively healthy populations, such as

vaccines, to antineoplastic agents used in patients affected

by a significant disease burden. Figure 3 provides the

classification of the drugs analysed in these publications

classified by Anatomical Therapeutic Chemical code [16]

with the exception of the last three sets of drugs (‘drugs

prescribed in geriatric setting’, ‘antibiotics’ and ‘all prod-

ucts in the database’) that cannot be allocated to a specific

Anatomical Therapeutic Chemical code.

Figure 4 provides the MedDRA� System Organ Classes

of the 53 publications describing safety issues with the

exception of the 11 publications aimed at characterising the

entire safety profile of the drugs. Two publications are

allocated to two different System Organ Classes.

The 46 (44%) publications describing general pharma-

covigilance topics contain research to analyse methodolo-

gies, especially on statistical signal detection, together with

descriptions of specific situations that should to be taken

into consideration when analysing safety data (e.g. paedi-

atric population or ADR reports from consumers). The

category related to signal detection methods includes

publications under the scope of the IMI PROTECT project

for which public funding was allocated [17–19].

Figure 5 provides the classification of the pharma-

covigilance topics yielded by the literature search.

One of the first publications on signal detection methods

in EV refers to the validation study performed by the EMA

to quantify the benefit that can be obtained by adding signal

detection using the proportional reporting ratio to estab-

lished pharmacovigilance methods. The study determined

that statistical analysis has the potential to provide signif-

icant early warning on adverse reactions to medicines [20].

Since then, 22 other publications have used EV data to

investigate signal detection methods. Choosing the

thresholds, comparison of disproportionality measures,

development of a score for the prioritisation of torsado-

genic signals and analysis of variables that could influence

signal detection in well-established products are among the

topics covered. Based largely on the research conducted

under the auspices of IMI PROTECT Work package 3

(signal detection) [19] [21], the EMA announced in 2015

the revision of the guidance of screening for adverse

reactions in EV [17]. The final guideline was published in

December 2016 [22]. This represents an important example

of research-based improvement in regulatory practice.

The six publications related to clinical perspectives refer

to the use of novel oral anticoagulants, in light of the

experience with dabigatran [23–26], information systems

Fig. 4 MedDRA� System Organ Class distribution for the specific safety issues described in the publications using EudraVigilance data up to 31

December, 2016. Absolute numbers. incl including

EudraVigilance Medicines Safety Database: Publicly Accessible Data 669

for translational pharmacogenomics [27] and the use of

sodium-glucose co-transporter 2 inhibitors with insulin for

the treatment of type 2 diabetes [28].

3 Changes in Adverse Drug Reaction ReportsManagement and Access to EudraVigilanceData

The EU pharmacovigilance legislation adopted in 2010

introduced significant changes in the management of

reports of suspected ADRs and placed EV as the single

European hub for ICSR exchange and access. These

changes include the submission of patient’s reports, non-

serious ADRs that occurred in the EU, and ADRs arising

from all uses of the medicinal products and not only those

restricted to authorised use.

In the area of signal detection, EV plays a key role in

determining new risks, new aspects of known risks and

changes in the benefit-risk balance of medicinal products

[2]. This comes with an explicit mandate for the EU reg-

ulatory network and the MAHs to monitor the data in EV.

During the decision-making process, the Pharmacovigi-

lance Risk Assessment Committee has a central role in

scientific assessment in relation to signal management,

covering all aspects of risk management. An analysis

published to describe signals during the first 18 months of

the Pharmacovigilance Risk Assessment Committee con-

firmed the importance of spontaneous reporting in signal

detection [29].

The collaboration with the WHO is also being

strengthened by making available all suspected ADRs

reported in the EEA to the Uppsala Monitoring Centre and

EV has undertaken the pertinent technical and process

modifications to achieve this. With the aim of increasing

transparency and to facilitate the conduct of safety moni-

toring and research, the level of access to EV has also been

enhanced. In addition to the full data access provided to the

EU regulatory network, MAHs are to have access to the

extent necessary to comply with their pharmacovigilance

obligations and an appropriate level of access is provided

to healthcare professionals and the public while guaran-

teeing personal data protection.

The EMA Management Board endorsed a revision of the

EudraVigilance access policy in December 2015 that

determines the level of access by stakeholder groups con-

sidering the need to protect personal data. This version of

the access policy takes into account the International

Council for Harmonization of Technical Requirements for

Pharmaceuticals for Human Use E2B(R3) [30] standard to

determine the level of access for all ICSR data elements.

The revision of the access policy categorises stake-

holders into six groups incorporating as new stakeholders

the WHO–Uppsala Monitoring Centre and medicines reg-

ulatory authorities in third countries (outside the EEA).

Nevertheless, the most significant update of the access

policy is in the level of access, the number of data fields

available, and the availability of new tools to access and

analyse the data. Table 1 outlines the access provided and

the tools for the different stakeholder groups.

Fig. 5 Classification of the pharmacovigilance topics analysed using EudraVigilance data up to 31 December, 2016. Absolute numbers. ADRs

adverse drug reactions

670 R. Postigo et al.

4 Research Organisations

In the context of EV access, academic research organisa-

tions should be understood as public or private higher

education establishments awarding academic degrees,

public or private non-profit research organisations whose

primary mission is to pursue research, and international

European interest organisations whose principal objective

is to promote scientific and technological cooperation in

Europe [32]. Until November 2017, the level of access to

EV data provided to academia and research organisations

was limited to the same set of data elements publicly

available in the ADR website. This is reflected in some of

the publications that analysed EV data for safety

Table 1 Level of EudraVigilance access provided by stakeholder group

Group Stakeholder Type of cases Access given (summary) Access method

I Medicines regulatory authorities in

EEA Member States, the European

Commission and the EMA

All cases Complete access (Level

3—272 data fields)

EVWEBa and

EVDASb

II Healthcare professionals and the

public

Spontaneousc Aggregated data

Line listing of individual

cases and ICSR form

(Level 1—53 data fields)

ADR website

III Marketing authorisation holders EVPMd cases Aggregated data with

statistical output (eRMR)

Line listing of individual

cases (Level 1—53 data

fields)

EVDAS

EVPM cases containing suspect/interacting

substances related to their products

XML file and ICSR form

(Level 2A—228 data

fields)

XML file (Level 2B—230

data fields, including the

narratives)

EVWEB

EVPM cases previously submitted by the

specific marketing authorisation holders and

medical literature monitoring cases

Complete access (Level

3—272 data fields)

EVWEB

IV Research organisations EVPM cases Level 2A—228 data fields

Data format will depend

on the nature of the

request

Research request

submission to

the EMA

V WHO-UMC EVPM cases XML file (level 2C—134

data fields)

Data transfer

between EMA

and WHO-

UMC

VI Medicines regulatory agencies in

third countries

EVPM cases Level 2C—134 data fields.

Data format will depend

on the nature of the

request

Request

submission to

the EMA

ADR adverse drug reaction, EEA European Economic Area, EDBMS EudraVigilance database management system, EMA European Medicines

Agency, eRMR electronic reaction monitoring report, EVDAS EudraVigilance data analysis system, EVPM EudraVigilance post-authorisation

module, EVWEB EudraVigilance web application, ICSR individual case safety report, WHO-UMC World Health Organization-Uppsala Mon-

itoring CentreaThe EVWEB is the interface to the EDBMS and allows registered users to create, send and view ICSRsbThe EVDAS supports European Union pharmacovigilance safety monitoring activities with the main focus on signal detection and evaluation of

ICSRscA spontaneous report is an unsolicited communication by a healthcare professional, or consumer to a competent authority, marketing autho-

risation holder or other organisation (e.g. regional pharmacovigilance centre, poison control centre) that describes one or more suspected adverse

reactions in a patient who was given one or more medicinal products. It does not derive from a study or any organised data collection system

[31]. Spontaneous reports are identified in the database by the mandatory field ‘type of report’ provided by the senders at the time of the ICSR

submissiondThe EVPM includes cases with type of report ‘spontaneous’, ‘other’ and ‘not available to sender (unknown)’ plus reports from studies

(including ‘individual patient use’ and ‘other study’)

EudraVigilance Medicines Safety Database: Publicly Accessible Data 671

assessments. The revision of the access policy extends the

access to data for research to provide the possibility for a

more thorough analysis of the data, hence contributing to

the promotion and protection of public health and fostering

innovation of scientific and medical research. Research

institutions can directly access level 1 data via the ADR

website and can also request the EMA level 2A data sets.

Figures 6 and 7 provide an overview of how research

institutions can access EV data.

The data provided in the ADR website include aggregated

information based on numbers of spontaneous cases stratified

by different parameters (e.g. number of cases by age group,

sex, geographic origin, reactions groups, time distribution).

From November 2017, the ADR website provides the possi-

bility to retrieve data for the individual cases based on some

core data elements (level 1) within the ‘patient characteris-

tics’, ‘reactions/events’ and ‘drugs information’ sections.

However, the data provided to research institutions upon

request contain a significant increase in the potential

number of data elements (level 2A) provided and the

access is extended to all cases submitted to the

EudraVigilance post-authorisation module, therefore not

restricted to spontaneous cases, and includes reports from

non-interventional post-authorisation studies.1 Within the

patient characteristics section and compared with level 1,

level 2A provides 83 extra data elements including,

amongst others, body weight and height, medical and

family history, past drug history, death details and infor-

mation concerning the parent for the parent–child reports.

The reaction section contains ten extra data elements

including the start and end dates of the reaction and the

identification of the country where the reaction occurred.

The drug section includes 49 extra data elements including

the product name for non-centrally authorised medicinal

products, strength, dates for the first and last drug admin-

istration, cumulative dose to first reaction, gestation period

at the time of exposure and batch/lot numbers. Further-

more, the data set contains 13 additional data elements for

the results of tests and procedures relevant to the investi-

gation of the patient. To comply with data protection

requirements, the case narratives, containing free text, are

not provided to research organisations.

To obtain level 2A access, the interested institutions

should submit a request via the EMA website [33] (http://

www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/

landing/ask_ema_landing_page.jsp&mid=) with details on

the research methodology, potential impact on public

health, a signed copy of the confidentiality undertaking

[32] and a copy of the approval of the research protocol by

an ethics committee/review body. Following the analysis of

the data, researchers should make all possible efforts to

publish the outcomes of the research and for information

purposes only, should provide a copy of the articles to the

EMA ahead of publication.

5 Data Protection

The need to maintain the confidentiality of the identity of

individuals in compliance with EU personal data protection

legislation [34, 35] is one of the key drivers of the EV

Researchins�tu�on

ADR reports websiteLevel 1 (53 data fields)

Direct accesswww.adrreports.eu

Aggregateddata

Individual casesdata

Line lis�ngs

ICSR forms

Data analysis

Fig. 6 Access to Level 1 EudraVigilance data by research organisations. ADR adverse drug reaction, ICSR individual case safety report

Fig. 7 Access to Level 2A EudraVigilance data by research organisations. EMA European Medicines Agency

1 Non-interventional studies are considered studies where the

medicinal product(s) is (are) prescribed in the usual manner in

accordance with the terms of the marketing authorisation. The

assignment of the patient to a particular therapeutic strategy is not

decided in advance by a trial protocol but falls within current practice

and the prescription of the medicine is clearly separated from the

decision to include the patient in the study. Non-interventional post-

authorisation studies are identified in the database by the mandatory

fields ‘type of report’ and ‘study type where the reactions events

occurred’.

672 R. Postigo et al.

access policy and the levels of access have been developed

considering data protection in conjunction with the public

health needs and pharmacovigilance obligations for the

different stakeholders. Users of EV should comply with the

data protection requirements and should have appropriate

measures in place to protect the information [32].

In this context, it is especially important to avoid the

identification of individual patients from the data available

in the ADR website published by the EMA. Level 1 access

is based on this principle while providing meaningful

information on suspected ADR reports. Table 2 outlines

additional measures taken in the ADR website to avoid the

identification of individual patients.

6 Discussion

Particularly since 2011, there has been a constant increase

in the number of research publications that considered data

from EV and this likely reflects the growing recognition of

how the database can contribute to drug safety. The sus-

pected ADR data in EV have provided a foundation to

identify safety signals and characterise risks. Furthermore,

the data have allowed the investigation of new method-

ologies for signal detection as well as specific situations

such as paediatrics, vaccines, pandemics, consumer reports

and traceability of biological products.

In 2016, Fouretier et al. [36] performed an analysis of 11

pharmacovigilance databases with open access to charac-

terise the accessibility of the relevant data in those systems.

In their study, the EV access was considered to be ‘med-

ium’, mainly based on the fact that EV did not provide

public access at the level of the individual cases in the

ADR website. This assessment and the perception of EV

will change drastically with the recent implementation of

the new access specified in the revised access policy.

The main implication for MAHs following the release of

the new EV system and extended access is the obligation to

monitor the data for their substances and products. The

extended access provided at the level of the substance

brings the opportunity for MAHs to fully assess the data

and provides greater transparency during assessment and

decision making. The applied statistical analysis follows an

evidence-based methodology [22] and this provides a

common understanding about how statistical signal detec-

tion has been implemented in EV.

Apart from the power demonstrated by statistical

methods within large spontaneous reporting systems [37],

statistical signal detection should be complemented by

scientific assessment and medical judgement, taking into

consideration what is known about the product. The

detailed analysis of individual cases remains one of the key

activities during assessments and can provide significant

information when determining causal associations.

At the same time as the new access is in place, the

International Council for Harmonization of Technical

Requirements for Pharmaceuticals for Human Use

E2B(R3) standard is implemented in EV with the subse-

quent advantages derived from the new data structure and

data elements. These will bring advantages for data anal-

ysis (e.g. in the old format, seriousness criteria are reported

at the level of the case whereas these are reported at the

level of the individual reactions in the new format). Safety

assessors should be well aware of the differences between

the old and the new format when analysing the data.

The enhanced access to the data is also expected to

trigger more engagement with academia. Up to November

2017, the information from EV publicly available could

have been considered acceptable for patient use but not

optimally for research purposes [36]. The extended access

provides research institutions with a rich data source and

there is therefore a unique opportunity to conduct research

for public health.

7 Conclusion

Pharmacovigilance is an essential discipline for the pro-

motion and protection of patient and public health. In the

EEA, the EU regulatory network formed by the European

Commission, the NCAs and the EMA has a key role

together with the MAHs on the safety surveillance on

medicinal products.

The EU legislation places the EV database in a core role

in the management of reports of suspected adverse reac-

tions and in determining changes in the safety profile of the

medicinal products once they are used in everyday medical

practice. For over 16 years, EV has demonstrated its value

especially in the area of signal detection, providing a tool

to analyse the safety data submitted.

Although EV has been fully accessible to the EMA and

the NCAs in the countries that belong to the EEA, the

access provided in the past to other stakeholders has been

more limited. The new extended EV access provides a

unique platform for all stakeholders to use the data

according to their needs, interest and pharmacovigilance

obligations. This enhanced access brings opportunities for

a broader involvement in safety monitoring, for increased

transparency, for collective collaborations, for methods

improvement and for innovation in safety research.

We call on patients, healthcare professionals, MAHs,

research institutions, the WHO, non-EEA regulatory

authorities, NCAs in the EEA Members States and the

EMA to embrace the opportunities provided by the new

EudraVigilance system to be better informed, to better

EudraVigilance Medicines Safety Database: Publicly Accessible Data 673

manage product risks, to better understand the science of

pharmacovigilance and, ultimately, to better promote

public health.

Acknowledgements The authors gratefully acknowledge the contri-

bution made by Luis Pinheiro.

Compliance with Ethical Standards

Funding No sources of funding were received for the preparation of

this review.

Conflict of interest Rodrigo Postigo, Sabine Brosch, Jim Slattery,

Xavier Kurz, Gianmario Candore, Francois Domergue and Peter

Arlett are employees of the European Medicines Agency. Jean-

Michel Dogne is a member of the Pharmacovigilance Risk Assess-

ment Committee, as well as an employee of the Federal Agency for

Medicines and Health Products of Belgium. Anja van Haren is an

employee of the Medicines Evaluation Board of the Netherlands and

she acts as a co-chair of the EudraVigilance Expert Working Group.

Disclaimer The views expressed in this article are the personal views

of the authors and may not be understood or quoted as being made on

behalf of or reflecting the position of the agencies or organisations

with which the authors are affiliated.

Open Access This article is distributed under the terms of the

Creative Commons Attribution-NonCommercial 4.0 International

License (http://creativecommons.org/licenses/by-nc/4.0/), which per-

mits any noncommercial use, distribution, and reproduction in any

medium, provided you give appropriate credit to the original

author(s) and the source, provide a link to the Creative Commons

license, and indicate if changes were made.

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Table 2 Adverse drug reaction website: additional measures for data protection

Measures

The information provided in the 53 data elements (level 1 access) individually or in combination would not lead to the identification of

individual patients, for instance, date of birth, or free text fields are not provided

Within the details of the individual cases, the country where the reaction occurred is not provided. The ‘country’ data field is displayed as

EEA or non-EEA. This is to prevent the identification of patients where there are a small number of cases per country

The product name for non-centrally authorised medicinal products is replaced by the substance name. Product names can potentially lead to

the identification of the country where the reaction occurred

The Worldwide Case Identification Number is replaced by the EV local report number as the country code is normally included in the

Worldwide Case Identification Number

The sender organisation is displayed as ‘EEA regulator’ for cases submitted by regulatory authorities from the EEA to avoid the

identification of the country

A threshold is applied if the number of individual cases available for a specific country is less or equal to 3. In this instance, the total number

of cases for the specific country is not provided to reduce the risk of patient or reporter identification

EEA European Economic Area, EV EudraVigilance

674 R. Postigo et al.

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